A federal judge in Texas ruled that the FDA-approved drug mifepristone should be removed from the market in the United States.
The ruling has not gone into effect, and the Biden administration has announced they will fight this decision.
On Friday evening, a federal judge in Texas ruled to suspend the U.S. Food and Drug Administration’s (FDA) approval of mifepristone, which is used to terminate a pregnancy up to 10 weeks. The case was brought by anti-abortion medical agencies, which claim, in part, that mifepristone poses a safety risk and causes adverse results.
Here’s what you need to know about the ruling.
Q: How does this ruling impact the FDA’s authority?
A: This ruling is unprecedented and President Biden has called it a “political” and “ideological” attack on the FDA’s authority, which first approved mifepristone 23 years ago. “The court in this case has substituted its judgment for FDA, the expert agency that approves drugs,” said President Biden in a statement.
In his decision, the Texas judge said the FDA “stonewalled” legal action and that the case would have been in federal courts decades earlier if not for the FDA’s procrastination.
Q: Will this reach the Supreme Court?
A: Since the Supreme court overturned Roe v. Wade last year, there has been a lot of push and pull involving abortion, states' rights and personal rights. It is very possible this issue will also reach the Supreme court. For now, the case will head to the 5th U.S. Circuit Court of Appeals, which leans conservative in view point.
Q: Can I still prescribe mifepristone to my patients?
A: Yes, another judge in Washington state passed an injunction. This injunction makes mifepristone available in 17 states and Washington D.C. The judge in Texas did stay his ruling for one week to allow the Biden administration a chance to appeal.
Q: What should I tell my patients?
A: Your patients may be worried about access to mifepristone. You may find it useful to remind them that there are other options if mifepristone does become unavailable. For example, pregnancy can be terminated using misoprostol only.